A Phase I Open-Label, Dose-escalation Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus (TILT-123) in Combination With Pembrolizumab in Patients With Immune Checkpoint Inhibitor Refractory Non-Small Cell Lung Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is an open label, Phase 1, dose escalation trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with Pembrolizumab in patients with immune checkpoint inhibitor refractory non-small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Histologically confirmed NSCLC cancer which cannot be treated with curative intent with available therapies and is refractory to or progressing after anti-PD(L)1 immunotherapy or immunotherapies.

⁃ At least one tumor lesion (\>15 mm or bigger) must be available for biopsy that in the opinion of the investigator, is accessible to repeated biopsies without major safety concerns.

⁃ The patient must have disease evaluable per RECIST 1.1

⁃ Have adequate organ function as defined in the following values below. Specimens must be collected within 10 days prior to the start of study treatment.

⁃ Hematological laboratory values

• Absolute neutrophil count (ANC): ≥1500/µL

• Platelets: ≥ 100 000/µL

• Hemoglobin: ≥9.0 g/dL or ≥5.6 mmol/L. Criteria must be met without packed red blood cell (pRBC) transfusion within the prior 2 weeks. Participants can be on stable dose of erythropoietin (≥ approximately 3 months.

• Leukocytes (WBC) \> 3.0

⁃ Renal laboratory values

• GFR: \>45 ml/min (Cockcroft-Gault formula).

• Hepatic laboratory values

• Total bilirubin: ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN (excluding patients with Gilbert's disease)

• AST (SGOT) and ALT (SGPT): ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)

⁃ Patients must be willing to use adequate forms of contraception from screening, during the trial, and for a minimum of 120 days after end of treatment.

⁃ ECOG/WHO performance score of 0-1 at screening.

⁃ Life expectancy longer than 3 months.

Locations
United States
California
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
UCLA Jonsson Comprehensive Cancer Center
NOT_YET_RECRUITING
Santa Monica
Contact Information
Primary
TILT Trials
trials@tiltbio.com
+358 509181 580
Time Frame
Start Date: 2024-07-23
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 22
Treatments
Experimental: TILT-123 and Pembrolizumab
Patients will receive multiple administrations of TILT-123 and Pembrolizumab.~Escalation to the next dose of TILT-123 will occur when the safety data has been evaluated for patients in the preceding dose level.
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: TILT Biotherapeutics Ltd.

This content was sourced from clinicaltrials.gov

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